Directive 2014/68/EU is a key legal act for manufacturers, importers and distributors of pressure equipment, regulating conformity assessment and safety rules. Learn the requirements related to CE marking, final inspection procedures and economic operators’ obligations when placing pressure equipment on the market.
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The PED (Pressure Equipment Directive) 2014/68/EU concerning the making available of pressure equipment on the European market is one of the most important legal acts for manufacturers of refrigeration equipment and heat pumps. Despite 10 years having passed since its creation, many doubts related to correct interpretation of the document still arise. Recently many myths and misleading information have accumulated, the repetition of which may create a risk of improper placing of pressure products on the Polish or European market. The article presents the most important requirements resulting from the PED directive, errors made, and examples concerning correct determination of the category of pressure equipment or assemblies.
One of the fundamental assumptions of the PED (Pressure Equipment Directive)
2014/68/EU was to harmonise national rules (among EU Member States) related to potential hazards caused by
pressure equipment and assemblies.
PLACING NEW PRODUCTS ON THE MARKET
There is no doubt that, from a formal point of view, one of the most important stages when preparing to place a new product on the market is drawing up an EU declaration of conformity for it by the manufacturer or authorised representative. This activity is accompanied by compiling full technical documentation, including inter alia: label, user instructions and information on the regulations which the given product meets.
The CE marking placed on the product indicates product conformity with the requirements of new approach directives and thus attests to fulfilment of requirements concerning safety, health and environmental protection.
Manufacturers very often ask how to confirm fulfilment of the requirements of individual directives. In some cases the assessment may be performed independently by the manufacturer. It should be borne in mind, however, that in appropriate cases participation of a third party – a notified body – in the conformity assessment process is necessary, for example at the production phase.
PARTICIPATION OF A NOTIFIED BODY
IN THE CONFORMITY ASSESSMENT PROCESS
When referring to Directive 2014/68/EU (PED) in the EU declaration of conformity, the manufacturer takes responsibility for fulfilment of the document’s requirements with regard to the pressure equipment or assembly of pressure equipment placed on the market. At this point a second question becomes relevant: Is participation of a notified body necessary in the case of the PED directive?
Above all this depends on the category of the equipment or assembly, which defines the degree of potential hazard caused by the given product. If the equipment is classified in a category not higher than I, the manufacturer is not obliged to use an assessment performed by a notified body. If, however, the product has been assigned to a higher category (e.g. II, III, IV), it is necessary to use the services of an entity authorised to perform conformity assessment – a notified body (Table 1).
The PED directive was implemented into Polish law by the “Regulation of the Minister of Development of 11 July 2016 on requirements for pressure equipment and assemblies of pressure equipment”. This document applies to pressure equipment and assemblies that reach a maximum allowable pressure (PS) exceeding 0.5 bar, and relates to activities connected with the design, production and conformity assessment phases.
SELECTED ORGANISATIONS
RESPONSIBLE FOR CONFORMITY ASSESSMENT
AND NOTIFICATION
A notified body (NB – notified body) is an independent, impartial organisation authorised to assess conformity (e.g. of products submitted by the manufacturer) with regard to fulfilment of requirements defined in individual European Union directives. Such a body is approved by the notifying authority, notified to the European Commission and individual EU Member States and published in the list of authorised bodies. Every notified body is subject to supervision by the national accreditation body and has an identification number assigned by the European Commission, e.g. number 1462 [1, 6].
Authorisation, i.e. confirmation of fulfilment of requirements by a conformity assessment body, is necessary for notifying it to the European Commission and is performed by the competent minister. For example, in Poland the Ministry of Development and Technology is responsible for the PED directive scope (competent minister) – notifying authority [7].
| Pressure category | Is participation of a notified body required in the conformity assessment process? | Is preparation of a declaration of conformity for the product required? |
|---|---|---|
| < I | no | no |
| I | no | yes |
| II, III, IV | yes | yes |
Table 1. Basic requirements concerning conformity assessment and drawing up of a declaration of conformity in accordance with the assumptions of Directive 2014/68/EU (source: [4])The national accreditation body in each EU Member State is an organisation authorised by the state to grant accreditation to bodies performing conformity assessment. In Poland this role is performed by the Polish Centre for Accreditation (PCA), which as a state legal person confirms the competence and impartiality and fulfilment of requirements of harmonised standards by the conformity assessment body.
HOW TO RECOGNISE A BODY ACCREDITED BY THE POLISH CENTRE FOR ACCREDITATION?
Accreditation symbols granted by PCA enable identification of accredited conformity assessment bodies, such as laboratories or certification bodies. The PCA symbol attests to confirmation of the organisation’s competence and can be found inter alia in test reports and certificates of conformity issued by bodies holding current accreditation.
In connection with the United Kingdom’s withdrawal from the European Union, from 1 January 2021 EU rules no longer apply in Great Britain. Therefore notified bodies from Great Britain lost the status of notified bodies under EU legislation. In Great Britain the UKCA marking (UK Conformity Assessed) was introduced for selected products placed on that market.
According to the PED directive, fluids should be understood as “gases, liquids and vapours in pure phase as well as mixtures thereof; a fluid may contain a suspension of solids”.
In connection with the United Kingdom’s withdrawal from the European Union, from 1 January 2021 the requirements of EU legislation no longer apply to Great Britain. Therefore notified bodies from Great Britain no longer have the status of notified bodies under EU legal requirements.
The UKCA marking (UK Conformity Assessed) applies to selected products placed on the market in Great Britain.
The PED directive covers various pressure products, including:
- Pressure vessels – equipment used to store fluids under pressure.
- Piping – pipe systems for transporting fluids under pressure.
- Pressure equipment – equipment that uses pressure to operate, such as compressors or boilers.
- Pressure components – component parts intended to work under pressure conditions.
These products must meet specified safety and quality requirements in order to be placed on the market.
WHAT PRESSURE PRODUCTS DOES THE PED DIRECTIVE COVER?
The concept of pressure equipment within the meaning of the PED directive refers to vessels, piping, safety accessories and pressure accessories. Assemblies of pressure equipment define several interconnected items of equipment whose task is to create an integrated and functional whole. Examples of such assemblies of pressure equipment may be:
- Heat pump – equipment that transfers heat from one place to another, often used in heating and cooling systems.
- Condensing unit – equipment that converts vapour to liquid by cooling.
- Chiller (liquid cooling unit) – equipment that produces chilled water for cooling systems.
- Refrigerated cabinet – a unit used to store and cool products in retail.
- Air conditioner – equipment for regulating air temperature and humidity.
Safety accessories are devices intended to protect pressure equipment against exceeding allowable values, for example safety valves and pressure switches.
Pressure accessories, on the other hand, are devices that perform operating functions and have pressure envelopes, for example sight glasses that enable visual monitoring of the state of liquid or gas in pressure equipment.
| Pressure equipment | Fluid group | Gases1 | Liquids2 |
|---|---|---|---|
| Vessels | Group 1 fluids | V > 1 (L) and PS x V > 25 (bar x L) or PS > 200 (bar) |
V > 1 (L) and PS x V > 200 (bar x L) or PS > 500 (bar) |
| Group 2 fluids | V > 1 (L) and PS x V > 50 (bar x L) or PS > 1 000 (bar) |
PS > 10 (bar) and PS x V > 10 000 (bar x L) or PS > 1 000 (bar) |
|
| Piping | Group 1 fluids | DN > 25 | DN > 25 and PS x DN > 2 000 (bar) |
| Group 2 fluids | DN > 32 and PS x DN > 1 000 (bar) |
PS > 10 (bar), DN > 200 and PS x DN > 5 000 (bar) |
1 Also applies to liquefied gases, vapours, gases dissolved under pressure and liquids whose vapour pressure at the maximum allowable temperature exceeds 0.5 bar above normal atmospheric pressure;
2 With vapour pressure at the maximum allowable temperature not exceeding 0.5 bar above normal atmospheric pressure;
3 Also applies to all fire extinguisher powders and cylinders for breathing apparatus.
The requirements also apply to:
- safety accessories and pressure accessories;
- pressure equipment (fired or otherwise heated) with a volume above 2 l that generates steam or superheated water at a temperature up to 110°C.
NOTE: pressure equipment and assemblies that have limit values lower than those defined in Art. 4.1 of the directive (also indicated in this table) must be designed and manufactured in a manner consistent with sound engineering practice of the given state in order to meet safety of use requirements.
HOW TO DETERMINE THE CATEGORY OF PRESSURE EQUIPMENT FOR REFRIGERATION EQUIPMENT AND HEAT PUMPS?
- Determining the fluid group (refrigerant)
The process of determining the category of pressure equipment should start with determining the fluid group intended for use in the given product. Assigning an incorrect fluid group at this stage will result in incorrect determination of the category of the entire equipment or assembly. According to the PED directive, fluids should be understood as “gases, liquids and vapours in pure phase as well as mixtures thereof; a fluid may contain a suspension of solids”. The directive provides for division of fluids into two groups: 1 and 2. Group 1 includes hazardous substances (inter alia flammable, explosive, oxidising, toxic, etc.), as well as fluids with a maximum allowable temperature (TS) exceeding the auto-ignition temperature of the given substance. Detailed classification of requirements for the listed substances is defined in Regulation (EC) No 1272/2008. Remaining fluids are classified in group 2. A list of fluids for refrigeration equipment and heat pumps (in this case refrigerants) together with the defined group (PED fluid group) can be found directly in Annex E to PN-EN 378-1 (PN-EN 378-1+A1:2021-03).
| Group 1 | Group 2 |
|---|---|
| R290 (propane) | R134a |
| R32 | R1234ze |
| R600 (butane) | R404A |
| R600a (isobutane) | R407C |
| R452B | R407F |
| R454B | R410A |
| R454C | R449A |
| R717 (ammonia) | R452A |
| R1234yf | R507A |
| R1270 (propylene) | R513A |
| R744 (carbon dioxide) |
- Determining the refrigerant phase (liquid or gas)
According to the provisions of the harmonised standard PN-EN 378-2 (PN-EN 378-2:2017-03), if the vapour pressure of a given refrigerant at the maximum allowable temperature (at the bubble point) exceeds 0.5 bar above normal atmospheric pressure, the fluid is classified as a gas; otherwise this fluid is treated as a liquid. - Determining the maximum allowable pressure PS
Pressure PS (maximum allowable pressure) means “the maximum pressure for which the equipment is designed, specified by the manufacturer and defined at a location specified by him, which is the location of connection of safety or limiting devices or the top of the equipment or, if this is not appropriate, any specified point”. Detailed information and requirements concerning determination of the maximum allowable pressure are contained in PN-EN 378-2. - Establishing volume (for vessels) or diameters (for piping)
By volume (V) the PED directive means “the internal volume of a pressure chamber, including the volume of nozzles to the first connection or weld, excluding the volume of solid internal parts”. When determining the category of piping, the nominal size (DN) should be established. - Performing calculations and using conformity assessment tables
Necessary calculations are usually limited to determining the PS x V relationship for pressure equipment treated as vessels, or PS x DN in the case of piping. Then the conformity assessment tables placed in Annex II of Directive 2014/68/EU should be used, on the basis of which it is possible to determine the category. Alternatively category classification may be performed using tables B.1 and B.2 placed in tabular form in PN-EN 378-2 (which is a document harmonised with Directive 2014/68/EU – a fragment is presented in Table 4) or using tables contained in the Regulation of the Minister of Development of 11 July 2016 on requirements for pressure equipment and assemblies of pressure equipment. According to Art. 2 and 4 of Directive 2014/68/EU, safety accessories are assigned to category IV. By way of exception they may be assigned to the category of the equipment they protect. Pressure accessories, in turn, are classified on the basis of pressure PS, volume or nominal size, and fluid group.
Heat exchangers may be treated as piping or vessels (this depends on the design and construction of the given equipment). Many compressors used in refrigeration must also meet PED directive requirements.
A situation is possible in which the maximum allowable pressure of a given item of equipment (forming an assembly) is higher than the PS pressure of the entire pressure assembly.
CATEGORY OF AN ASSEMBLY OF EQUIPMENT
Fragment of the conformity assessment table for vessels containing a group 1 fluid in the gas phase
Source:
| Fluid (fluid group) (1) |
Type (refrigerant phase) (2) |
Pressure PS (bar) (3) |
Volume V (l) (4) |
PS x V (bar x l) (5) |
Category (or article) |
|---|---|---|---|---|---|
| GROUP 1 | GAS | ≤ 0.5 | - | - | Not subject to PED1 |
| > 0.5 and ≤ 200 | ≤ 1 | ≤ 25 | Art. 4.3 of PED directive2 | ||
| > 0.5 and ≤ 200 | > 1 | ≤ 25 | Art. 4.3 of PED directive2 | ||
| > 0.5 and ≤ 200 | > 1 | > 25 and ≤ 50 | I | ||
| > 0.5 and ≤ 200 | > 1 | > 50 and ≤ 200 | II | ||
| > 200 and ≤ 1 000 | ≤ 1 | - | III | ||
| > 200 and ≤ 1 000 | > 1 | ≤ 1 000 | III | ||
| > 1 000 | - | - | IV | ||
| ≤ 0.5 | - | - | Not subject to PED1 |
1 category lower than I
2 sound engineering practice (SEP) rules apply
When determining the category of the entire assembly (e.g. a heat pump), the categories of the individual pressure equipment items forming the given assembly should first be established. The category of the assembly is then determined on the basis of the highest category of pressure equipment forming part of the assembly.
Table 5. Summary of categories of pressure equipment and assemblies together with available conformity assessment procedures (source: prepared on the basis of )
module A
module A2
module D1
module E1
modules B (design type) + D
modules B (design type) + F
modules B (production type) + E
modules B (production type) + C2
module H
modules B (production type) + D
modules B (production type) + F
module G
module H1
A situation is possible in which the maximum allowable pressure of a given item of equipment (forming an assembly) is higher than the PS pressure of the entire pressure assembly. Most often the PS pressure value of the given assembly of equipment is used to determine the category (in which case the safety accessory used to protect the given pressure equipment should have the PS value of the assembly set). Conversely, when the safety accessory has the PS value of the given equipment set, the protected pressure equipment should have its category determined on the basis of the PS pressure assigned to that equipment.
After determining the category of the pressure equipment (or assembly), the next step is to establish the conformity assessment procedure – the so-called module. For this purpose the manufacturer chooses the procedure that will be applied to the conformity assessment process and, where appropriate, submits an application to a notified body. The manufacturer is entitled to indicate a conformity assessment procedure (module) of his choice that relates to a category higher than required (if it is available).
FINAL INSPECTION
In order to verify the safety and conformity of pressure equipment it is necessary for the manufacturer to perform a final assessment, which includes:
- Final inspection (covering: visual assessment, verification of documents to confirm conformity with the directive and, where applicable, tests);
- Performing a strength test;
- Inspection of safety devices.
For some conformity assessment procedures (where third-party intervention is required), the notified body indicated by the manufacturer during visits to the manufacturer verifies the final assessment performed. In particular the body establishes whether the manufacturer actually performs the final assessment and then verifies its quality level. For this purpose samples of pressure equipment are taken (the number of equipment items in the sample and the scope of final assessment verification is determined by the notified body). If non-conformities are found, appropriate measures must be taken.
The strength test usually includes performing a hydraulic pressure test. Directive 2014/68/EU defines hydraulic test pressures. According to the document, for vessels the hydraulic test pressure must not be lower than:
- “The pressure corresponding to the maximum loading to which the pressure equipment may be subject in service, taking into account the maximum allowable pressure and the maximum allowable temperature, multiplied by a coefficient of 1.25”;
- “The maximum allowable pressure multiplied by a coefficient of 1.43, whichever is higher” (PS x 1.43).
In special cases it is possible to perform other tests of recognised value. If equipment belongs to category I and is manufactured in series, the strength test may be performed on a statistical basis.
MANUFACTURER VERSUS DISTRIBUTOR AND IMPORTER
Every economic operator (including importer or distributor) who places pressure equipment or an assembly on the market:
- Under his own name;
- Under his own trademark;
- Modifying pressure equipment or assemblies in a way that may affect product conformity with the requirements of Directive 2014/68/EU,
should be regarded as the manufacturer and take over his obligations.
Obligations of economic operators are contained in Chapter 2 of the PED directive. Among the distributor’s obligations one can indicate inter alia checking that products have CE marking, required documents, operating instructions and safety information. Importers should include their data on the packaging or a document accompanying equipment and assemblies placed on the market.
The EU declaration of conformity and technical documentation should be retained for 10 years from placing the assemblies or pressure equipment on the market.
IDENTIFICATION NUMBER OF THE
NOTIFIED BODY
If, according to the requirements of EU legislation, a notified body participates in production control, then after the CE marking it is necessary to place its identification number. Identification numbers and the list of authorised notified bodies approved by the European Commission can be checked in the NANDO database.
The identification number of the notified body should only be placed when it is involved in the production phase. The body number is not placed when the notified body participates in the design phase (e.g. under module B). Details are contained in Table 6.
Table 6. Use of the notified body identification number after the CE marking. (source: prepared on the basis of )
| CE marking includes the notified body identification number | CE marking does not include the notified body identification number | ||
|---|---|---|---|
 1462 |
in the production phase a notified body is involved that performs conformity assessment (e.g. module A2 – category II) |
|
in the production or design phase no notified body is involved (e.g. module A – category I) |
|
in the design assessment phase (e.g. module B), and at the manufacturer’s request also in the production phase, a notified body is involved. An example may be another module following module B. NOTE: the module following module B does not have to be assessed by the same body that performed conformity assessment in the area of module B. |
by the manufacturer’s choice an accredited in-house body is involved in the production phase* * An in-house body forms part of the manufacturer’s organisation (this situation usually occurs in specific circumstances e.g. for complex, advanced products). The said body may not have tasks other than conformity assessment. In connection with the above the in-house body is obliged to maintain full independence from units involved in design, production and trade. |
||
|
in the design assessment phase (e.g. module B) and in the production phase a notified body is involved. An example may be another module following module B. NOTE: the module following module B does not have to be assessed by the same body that performed conformity assessment in the area of module B. |
in the design assessment phase (e.g. module B) a notified body is involved, whereas no notified body participates in the production phase | ||
| in the design assessment phase and in the production phase a notified body is involved (e.g. modules D1, E1, F1, H, H1). | in the design assessment phase (module B) a notified body is involved, whereas in the production phase by the manufacturer’s choice an accredited in-house body participates. | ||
ERRORS AND NON-CONFORMITIES
Example non-conformities and errors occurring when applying Directive 2014/68/EU are:
- Placing the CE marking in violation of regulatory requirements, including lack of involvement of a notified body for conformity assessment when the pressure equipment or assembly is classified in category II, III or IV.
- Lack of the notified body identification number if it is involved at the production control stage.
- Using charge (expressed in kg) instead of volume (expressed in litres) to determine the category. Knowledge of vessel volumes and piping diameters is necessary, which requires knowledge of the product technical specification.
- Incorrect determination of the fluid group (refrigerant), caused by referring to other refrigerant classification systems used in refrigeration (e.g. refrigerant R32 classified as A2L according to ASHRAE Standard 34, whereas according to PED guidelines it is classified in group 1).
- Drawing up the EU declaration of conformity in an incorrect manner.
- Lack of complete technical documentation.
- Incorrect interpretation of the directive resulting from lack of reference to harmonised standards concerning the equipment under consideration and the scope.
- Incorrect manner of performing final assessment by manufacturers (e.g. incorrect pressure strength test pressures).
- Lack of confirmation of metrological traceability of measuring instruments used for final assessment by manufacturers.
- Abuse by manufacturers of directive provisions (e.g. Art. 1) in order to exclude application of the document to certain pressure equipment or assemblies, e.g. incorrect reference to the Machinery Directive or unjustified treatment of assemblies as partly completed machinery.
SUMMARY
In an era of widespread use of flammable refrigerants in refrigeration equipment and heat pumps, particular attention when analysing the PED directive (2014/68/EU) at the stage of preparing to place products on the market is essential. Key aspects are:
- Obligations of economic operators: Manufacturers, importers and distributors must be aware of their obligations resulting from the directive, including requirements concerning documentation and conformity with regulations.
- EU declaration of conformity: The documentation must contain all elements required in Annex IV of the directive, which includes inter alia technical data, a description of the conformity assessment procedure and safety information.
- Personnel performing permanent joints: For equipment classified in categories II, III and IV, personnel responsible for joints (e.g. brazed or welded) must be approved by a third party, such as a notified body. This also concerns requirements related to approval of operating procedures for these joints and recognition of brazing and welding technologies.
Taking care of these elements is key to ensuring product safety and conformity, especially in the context of use of flammable refrigerants
References:
- CE marking. (source: europa.eu).
- NANDO (New Approach Notified and Designated Organisations) Information System; Single Market Compliance Space, European Commission (source: webgate.ec.europa.eu).
- Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment.
- PN-EN 378-2:2017-03 “Refrigerating systems and heat pumps – safety and environmental requirements – Part 2: Design, construction, testing, marking and documentation”.
- Regulation of the Minister of Development of 11 July 2016 on requirements for pressure equipment and assemblies of pressure equipment; Journal of Laws item 1036 as amended.
- The Blue Guide – Implementation of EU product rules 2022. (2022/C 247/01).
- Safety of products and services. Ministry of Development and Technology. (source: www.gov.pl).
- Information about PCA. Polish Centre for Accreditation (source: pca.gov.pl).
- Guidance. Using the UKCA marking (source: www.gov.uk).
- Materials of the Central Refrigeration Centre “COCH” in Kraków.
- PN-EN 378-1+A1:2021-03 “Refrigerating systems and heat pumps - safety and environmental requirements – Part 1: Basic requirements, definitions, classification and selection criteria”.
- Materials of HKS Lazar Sp. z o.o. (published with the company’s consent).
- Harmonised standards. Polish Committee for Standardization (source: www.pkn.pl).
Author: MSc Eng. Miłosz GRATKOWSKI –– Central Refrigeration Centre “COCH” in Kraków, Notified Body No. 1462
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CE and PED conformity assessment
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